Updated Perinatal Guidelines

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Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States

Integrase Inhibitors

Elvitegravir (Stribild, EVG/COBI/TDF/FTC)

CarcinogenicityElvitegravir was not genotoxic or mutagenic in vitro. No carcinogenicity was detected in long-term studies in mice at exposures up to 14-fold and rats at exposures up to 27-fold that achieved with human systemic exposure at the recommended dose.1

Reproduction/Fertility
Elvitegravir did not affect fertility in male and female rats at approximately 16- and 30-fold higher exposures than in humans at standard dosing. Fertility was normal in offspring.1

Teratogenicity/Developmental Toxicity
Studies in rats and rabbits have shown no evidence of teratogenicity or effect on reproductive function with elvitegravir.1
Placental and Breast Milk Passage
No data on placental passage are available for elvitegravir. Studies in rats have demonstrated that elvitegravir is secreted in breast milk.

Human Studies in Pregnancy

Pharmacokinetics
Pharmacokinetic (PK) studies of elvitegravir in human pregnancy are limited to a single case report of elvitegravir and cobicistat PK, safety, and efficacy in a single pregnant woman. Elvitegravir and cobicistat pharmacokinetics were assessed in this woman at 34 weeks’ gestation and repeated at 6 weeks postpartum. Elvitegravir area under the curve (AUC) was similar during pregnancy and postpartum, but Cmin was reduced by 60% during pregnancy compared to postpartum (and was below the suggested target concentration of 0.13 mg/L). Cobicistat AUC was reduced by 44% during pregnancy compared to postpartum. Despite the low elvitegravir Cmin, viral load remained undetectable throughout the pregnancy.2

Placental and Breast Milk Passage
The only data available on placental passage of elvitegravir in humans are from the single case report cited above. At delivery, maternal and cord blood plasma elvitegravir concentrations were both 0.30 mg/L.2 No data are available on human breast milk transfer of elvitegravir.

Teratogenicity/Developmental Toxicity
In the Antiretroviral Pregnancy Registry, insufficient numbers of first-trimester exposures to elvitegravir in humans have been monitored to be able to make a risk determination.3